"PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You"ll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients." |
Designation | Clinical Data Analyst II |
Job Description | Requirements Clinical Data Analyst II - 3 to 6 years of Relevant Clinical Data Management Experience. Candidates should have experience in all three stages of a Study. Prior experience in the Conduct and Lock Stage is desired. Job Location - Hyderabad Advance your career at PAREXEL Life-saving work brings people from all over the world to PAREXEL. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. Additionally, we have supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and youll have the chance to make a profound difference in millions of lives. Youll be immersed in diverse projects that keep you challenged every day, and surrounded by colleagues who share your passion to help bring our treatments to people in need. Working in a collaborative, supportive environment, your colleagues will share your passion to help bring our treatments to those in need. Youll also receive the training and development you need to achieve your personal and professional goals. Job Description Key Accountabilities - Assume the ability to meet the requirements of a CDA with a high degree of proficiency and autonomy - Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects - Train team members on selected tasks - Prepare Data Cleaning Specification - Review the Data Validation Specification prepared by the Technical Analyst in GTS - Develop or provide input to project specific guidelines, e.g. SAE handling. - Initiate the running of study specific programs - Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc. - Conduct in-house data review, - Generate and close queries or apply self-evident corrections to the data according to the relevant guidelines - Identify and report protocol violations - Manual and Patient Profile review, issue queries - Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action - Track and integrate queries - Perform clinical coding if appropriate to role within the project team - If required liaise with 3rd party vendors to clean electronic data - Ensure all documents coded for submission to central files - Lock site(s) within EDC system - remove user's data modification privileges - Interact with site (via mail) as required - Perform early and final database QC activities - Update all relevant tracking system on an ongoing basis - Inform responsible CDA Coordinator of work status regularly - Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor Skills - Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of MS-Office products such as Excel, Word - Sound awareness of all relevant regulations, including GCP - Ability to successfully work in a (virtual) team environment - Client focused approach to work - Effectively applies knowledge to provide advice or solutions based on expertise - Offers support and constructive feedback to project team members - Seeks opportunities to develop experience and knowledge - Ability to organize and plan tasks - Excellent interpersonal, verbal and written communication skills - Must be able to work independently but seek guidance when necessary, escalating issues as required - Sense of urgency in completing assigned tasks - Meticulous attention to detail - Effective time management in order to meet daily metrics or team objectives - Shows commitment to and performs consistently high quality work - Willing and able to travel as required local or international For more details contact Sumaja.Nayini@parexel.com or call 040 4437 9362 For more information about PAREXEL International visit www.PAREXEL.com |
Desired Profile | Please refer to the Job description above |
Experience | 3 - 8 Years |
Industry Type | IT-Software / Software Services |
Role | Team Lead/Technical Lead |
Functional Area | IT Software - Application Programming, Maintenance |
Education | UG - Any Graduate - Any Specialization, Graduation Not Required PG - Any Postgraduate - Any Specialization, Post Graduation Not Required DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required |
Location | Hyderabad / Secunderabad |
Keywords | Clinical Data Management CDACDCEDC |
Contact | PAREXEL International (India) Pvt Ltd Apply Here: http://jobsearch.naukri.com/job-listings-Clinical-Data-Analyst-II-PAREXEL-International-India-Pvt-Ltd--Hyderabad-Secunderabad-3-to-8-250913002826?xp=8&xz=7_0_5&xo=14808&id=a498834a4887452bab9078cc84c2904bd3898844100eb37f79badd39036dfb5feb2288ea5cb5280a|X|Y|X|U&xid=138112838477992400&qc=325699&qs=p&qt=all&enableRoleMapping=y&mode=7 |
sumaja.nayini@parexel.com | |
Website | https://parexel.com |
Job Posted | 07 Oct |
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